Skip to content

A study to check the safety and teeth whitening benefits of an oral care product in healthy humans.

To evaluate the in vivo safety & efficacy of an oral care formulation in terms of Teeth Whitening effect on healthy male and female participants - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/113297
Enrollment
33
Registered
2026-07-02
Start date
Unknown
Completion date
Unknown
Last updated
2026-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: STIM Spark PAP Advanced Whitening Toothpaste: Product is used to brush the teeth twice in a day at morning and night for the period of 14 days Control Intervention1: Nil: NA

Sponsors

GLOBAL DENT AIDS PVT LTD
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Indian / Asian male and female subjects 2.Healthy subjects 3.Having a habit of consuming hot/cold/sweet/beverages 4.Smokers and non-smokers may be included; smoking status will be recorded in CRF. 5.Having Oral Cavity. 6. Having Natural teeth discolouration. 7. Dehydration may make the teeth appear whiter than the actual shade. Make sure the participant s teeth are not too dry. 8.Shade selection should be made quickly and accept first decision. Eyes usually tire after 5 7 seconds. 9.Avoid bright colours in the environment. Lipstick, make up, tinted eyeglasses, jewellery, bright-coloured clothes must be removed from the participant and the evaluator.

Exclusion criteria

Exclusion criteria: 1)For Females: Being pregnant or breastfeeding or having stopped breastfeeding in the past three months. 2)Having refused to give his/her assent by not signing the consent form 3)Taking part in another study liable to interfere with this study 4)Being allergic to use of powder, removal cream/ spray on study site. 5)Being insulin-dependent diabetic or non insulin-dependent diabetic with a recent therapy (less than 6 months) 6)Having a progressive asthma (either under treatment or last fit in the last 2 years) 7)Having a chronic dermatosis liable to modify the cutaneous reactivity on the tested area (except for specific studies on a determined dermatosis) 8)Having non stabilized thyroid problems (requirement of a stabilized treatment for at least 6 months) 9)Being epileptic. 10)Following a chronic medicinal treatment comprising any of the following products: aspirin-based products, anti-inflammatories, anti-histamines, corticotherapy, taken by general or local routes (the only medication permitted is paracetamol). 11)Having cutaneous hypersensitivity. 12)Having a diagnosed or highly probable allergy to one or several compounds of the cosmetic products. 13)Having undergone a surgery requiring a general anaesthetic of more than one hour in the past 6 months. 14)Having changed cosmetic habits except those required by the protocol in the 14 days preceding the start of the study on the studied anatomic unit.

Design outcomes

Primary

MeasureTime frame
Teeth Whitening effectTimepoint: Baseline, day 7, day 14

Secondary

MeasureTime frame
NilTimepoint: NA

Countries

India

Contacts

Public ContactDr Mohit Lalvani

MASCOT-SPINCONTROL India Pvt. Ltd.

doctors@mascotspincontrol.in08657063276

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Sep 19, 2026